2015 Medicines in Development -- Leukemia & Lymphoma A Report on Cancers of the Blood Hematological Malignancies Product Name Sponsor Indication Development Status ABT-199/GDC-0199 AbbVie hematological malignancies Phase I (Bcl-2 inhibitor) North Chicago, IL (see also leukemia, lymphoma) www.abbvie.com Genentech www.gene.com South San Francisco, CA AG-120 Agios Pharmaceuticals advanced hematological malignancies Phase I (IDH1 inhibitor) Cambridge, MA www.agios.com AGS67E Agensys relapsed/refractory lymphoid malignancies Phase I (antibody drug conjugate) Santa Monica, CA www.agensys.com ALT-803 Altor BioScience hematological malignancies Phase I/II (IL-15 superagonist complex) Miramar, FL (see also myeloma) www.altorbioscience.com AMG 319 Amgen hematological malignancies Phase I (PI3K-delta inhibitor) Thousand Oaks, CA www.amgen.com AMG 900 Amgen hematological malignancies Phase I (aurora kinase inhibitor) Thousand Oaks, CA www.amgen.com anti-LAG3 Bristol-Myers Squibb hematological malignancies Phase I Princeton, NJ www.bms.com APTO-253 Aptose Biosciences relapsed/refractory hematological malignancies Phase I (MTF-1 inhibitor) San Diego, CA www.aptose.com Hematological Malignancies Product Name Sponsor Indication Development Status AR-42 Arno Therapeutics relapsed/refractory hematological malignancies Phase I/II (pan-DAC inhibitor) Flemington, NJ www.arnothera.com AZD9150 AstraZeneca hematological malignancies Phase I (STAT3 inhibitor) Wilmington, DE www.astrazeneca.com Isis Pharmaceuticals www.isispharm.com Carlsbad, CA BGJ398 Novartis Pharmaceuticals hematological malignancies Phase II (FGF-R kinase inhibitor) East Hanover, NJ www.novartis.com BKM120 Novartis Pharmaceuticals hematological malignancies Phase II (PI3K inhibitor) East Hanover, NJ www.novartis.com BPX-501 Bellicum Pharmaceuticals bone marrow transplantation in Phase I/II (T cell replacement therapy) Houston, TX hematological malignancies www.bellicum.com CB-839 Calithera Biosciences hematological malignancies Phase I (glutaminase inhibitor) South San Francisco, CA www.calithera.com duvelisib AbbVie advanced hematological malignancies Phase I (PI3K-delta/gamma inhibitor) North Chicago, IL (see also leukemia, lymphoma) www.abbvie.com Infinity Pharmaceuticals www.infi.com Cambridge, MA entopletinib Gilead Sciences hematological malignancies Phase II (Syk inhibitor) Foster City, CA www.gilead.com Hematological Malignancies Product Name Sponsor Indication Development Status FF-10501 Boston Strategics hematological malignancies Phase I/II (cell differentiation stimulant) Boston, MA www.bostonstrategics.com FUJIFILM Pharmaceuticals USA Boston, MA GS-4059 Gilead Sciences B-cell malignancies Phase II (Btk inhibitor) Foster City, CA www.gilead.com GS-9901 Gilead Sciences hematological malignancies Phase I (PI3K-delta inhibitor) Foster City, CA www.gilead.com HDM201 Novartis Pharmaceuticals hematological malignancies Phase I (tumor suppressor protein East Hanover, NJ www.novartis.com p53 modulator) HSC835 Novartis Pharmaceuticals hematological malignancies Phase I/II (stem cell therapy) East Hanover, NJ www.novartis.com INCB39110+INCB40093 Incyte B-lymphoid malignancies Phase II (JAK1+PI3K-delta inhibitor) Wilmington, DE www.incyte.com INCB52793 Incyte advanced hematological malignancies Phase I (JAK1 inhibitor) Wilmington, DE www.incyte.com JCAR014 Juno Therapeutics adult B-cell malignancies Phase I/II (T lymphocyte immunotherapy) Seattle, WA www.junotherapeutics.com Keytruda® Merck hematological malignancies Phase I pembrolizumab Whitehouse Station, NJ (see also myeloma) www.merck.com Hematological Malignancies Product Name Sponsor Indication Development Status LDE225 Novartis Pharmaceuticals PTCH1 or SMO-activated hematological tumors Phase II (Smo antagonist) East Hanover, NJ (see also leukemia, myeloproliferative) www.novartis.com LEE011 Novartis Pharmaceuticals hematological malignancies Phase II (CDK4/6 inhibitor) East Hanover, NJ (CDK4/6 pathway activation) www.novartis.com MEDI-551+rituximab MedImmune hematological malignancies Phase I (anti-CD19 mAb+anti-CD20 mAb) Gaithersburg, MD (see also leukemia, lymphoma) www.medimmune.com MRX34 Mirna Therapeutics hematological malignancies Phase I (liposome-encapsulated Austin, TX www.mirnarx.com miR-34 mimic) NiCord® Gamida Cell hematological malignancies Phase I/II cord blood stem cell therapy Jerusalem, Israel www.gamida-cell.com OMP-52M51 GlaxoSmithKline hematological malignancies Phase I (NOTCH-1 inhibitor) Research Triangle Park, NC www.oncomed.com OncoMed Pharmaceuticals Redwood City, CA Opdivo™ Bristol-Myers Squibb hematological malignancies Phase I nivolumab Princeton, NJ (see also leukemia, lymphoma, myeloma) www.bms.com oprozomib Onyx Pharmaceuticals relapsed/refractory hematological malignancies Phase I/II (proteasome inhibitor) South San Francisco, CA (see also myeloma) www.onyx.com Orphan Drug Hematological Malignancies Product Name Sponsor Indication Development Status RG7388 Genentech hematological malignancies Phase I (MDM2 antagonist) South San Francisco, CA www.gene.com SAR3419 Sanofi US B-cell relapsed/refractory malignancies Phase II (maytansin-loaded anti-CD19 mAb) Bridgewater, NJ www.sanofi.com SL-401 Stemline Therapeutics blastic plasmacytoid dendritic cell Phase I/II (IL-3R inhibitor) New York, NY neoplasms www.stemline.com Leukemia & Lymphoma Society (see also leukemia, myeloproliferative) www.lls.org White Plains, NY SNX-5422 Esanex refractory hematological malignancies Phase I (Hsp90 inhibitor) Indianapolis, IN StemEx® Gamida Cell-Teva Joint Venture hematological malignancies Phase II/III completed carlecortemcel-L Jerusalem, Israel (Fast Track) www.gamida-cell.com Orphan Drug TAK-659 Millennium Pharmaceuticals hematological malignancies Phase I (SYK kinase inhibitor) Cambridge, MA www.millennium.com TGR-1202 TG Therapeutics hematological malignancies Phase I (PI3K-delta inhibitor) New York, NY www.tgtherapeutics.com TKI258 Novartis Pharmaceuticals hematological malignancies (pathway activated) Phase II (dovitinib) East Hanover, NJ www.novartis.com Hematological Malignancies Product Name Sponsor Indication Development Status TZ101 Targazyme cord blood stem cell transplantation Phase I/II (human recombinant enzyme) San Antonio, TX for hematological malignancies www.targazyme.com Orphan Drug ulocuplumab Bristol-Myers Squibb hematological malignancies Phase I (anti-CXCR4) Princeton, NJ www.bms.com urelumab Bristol-Myers Squibb hematological malignancies Phase I Princeton, NJ (see also myeloma) www.bms.com urelumab+Opdivo™ Bristol-Myers Squibb hematological malignancies Phase I nivolumab Princeton, NJ www.bms.com varlilumab Celldex Therapeutics hematological malignancies Phase I (CD27 antigen inhibitor) Hampton, NJ www.celldex.com WT2725 Sunovion Pharmaceuticals hematological malignancies Phase I (cancer immunotherapy) Marlborough, MA www.sunovion.com Leukemia Product Name Sponsor Indication Development Status Å6 peptide Angstrom Pharmaceuticals chronic lymphocytic leukemia (CLL) (1st-line), Phase II (CD44 antigen stimulant) Solana Beach, CA small lymphocytic leukemia (1st-line) www.angstrominc.com ABL001 Novartis Pharmaceuticals chronic myeloid leukemia (CML), Philadelphia- Phase I (Bcr-Abl kinase inhibitor) East Hanover, NJ positive acute lymphoblastic leukemia (Ph+ ALL) www.novartis.com Leukemia Product Name Sponsor Indication Development Status ABT-199/GDC-0199 AbbVie relapsed/refractory CLL (combination therapy), Phase III (Bcl-2 inhibitor) North Chicago, IL CLL (1st-line) (combination therapy) www.abbvie.com Genentech (see also hematological, lymphoma) www.gene.com South San Francisco, CA relapsed/refractory CLL (17pdel) Phase II www.abbvie.com www.gene.com CLL (combination therapy) Phase I www.abbvie.com www.gene.com ACP-196 Acerta Pharma relapsed/refractory B-cell CLL, Phase II (Btk inhibitor) San Carlos, CA small lymphocytic leukemia www.acerta-pharma.com National Institutes of Health (see also lymphoma) Rockville, MD ACP-319 Acerta Pharma B-cell ALL (combination therapy) Phase I/II San Carlos, CA (see also lymphoma, myeloma) www.acerta-pharma.com relapsed/refractory CLL (combination therapy) Phase I www.acerta-pharma.com ADI-PEG 20 Polaris Pharmaceuticals acute myeloid leukemia (AML) Phase II (PEG arginine deiminase) San Diego, CA (see also lymphoma) www.polarispharma.com Leukemia Product Name Sponsor Indication Development Status AG-221 Agios Pharmaceuticals AML Phase I (IDH2 inhibitor) Cambridge, MA www.agios.com Orphan Drug Celgene www.celgene.com Summit, NJ alvocidib Tolero Pharmaceuticals AML (1st-line) Phase II (CDK inhibitor) Lehi, UT www.toleropharma.com Orphan Drug relapsed/refractory AML Phase I www.toleropharma.com AMG 232 Amgen AML Phase I (MDM2 inhibitor) Thousand Oaks, CA www.amgen.com anti-CD22-CAR transduced T-cells Opus Bio ALL Phase I Gaithersburg, MD (see also lymphoma) www.opusbio.com National Cancer Institute Bethesda, MD Arzerra® GlaxoSmithKline relapsed CLL Phase III ofatumumab Research Triangle Park, NC (see also lymphoma) www.gsk.com Orphan Drug ASP2215 Astellas Pharma US relapsed/refractory AML Phase I/II (gilteritinib) Northbrook, IL www.astellas.com AST-VAC1 Asterias Biotherapeutics AML Phase II completed (telomerase-based cancer vaccine) Menlo Park, CA www.asteriasbiotherapeutics.com Leukemia Product Name Sponsor Indication Development Status ATTCK20 Unum Therapeutics CLL Phase I (viral-ACTR+anti-CD20) Cambridge, MA (see also lymphoma) www.unumrx.com bendamustine ready-to-dilute Eagle Pharmaceuticals CLL application submitted liquid formulation Woodcliff